View Clinical Trial (Medical Research Study)
Endothelial Function and Arterio-Venous Fistula Maturation
| City: |
|
San Francisco |
| State: |
|
California |
| Zip Code: |
|
94143 |
| Conditions: |
|
Chronic Kidney Disease |
| Purpose: |
|
An arterio-venous fistula is a surgical procedure that supports access for people undergoing
hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks
to better understand the factors that contribute to the successful maturation of an
arterio-venous fistula. A primary aim of this study is to see if endothelial function (the
biochemical events initiated by cells lining the arteries) is associated with successful
maturation. Other aims include determining if pro-inflammatory markers in the blood or
evidence of gene expression are associated with successful maturation.
|
| Study Summary: |
|
Current practice guidelines stipulate that 65% of all prevalent ESRD patients should receive
HD through some sort of arterio-venous fistula (AVF). An AVF is a subcutaneous, permanent
vascular access created surgically by connecting a vein with an artery and is the preferred
mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts
or tunneled lines. An AVF is mature if it can sustain high quality HD. However, rates of
primary failure (the inability of an AVF to sustain HD) are high, ranging from 40-70%.
Traditional coronary risk factors such as hypertension, hypercholesterolemia, and diabetes
mellitus, have limited ability to allow surgeons to predict which AVFs will mature.
One possible explanation involves vascular remodeling, the structural changes which occur in
a blood vessel in response to hemodynamic stimuli. The endothelial, lying at the interface
of the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow
and pressure. It initiates a complex biological response including cellular proliferation
and migration, matrix degradation, and cellular apoptosis. This longitudinal, observational
study hypothesizes that endothelial function is a critical modulator of AVF maturation.
Specifically, that patients with inflammation will have impaired endothelial function and
demonstrate less significant remodeling than others.
|
| Criteria: |
|
Inclusion Criteria:
- Chronic Kidney Disease classification Stage IV or V
- Adequate quality cephalic or basilic vein based on pre-operative assessment
- Able to provide written informed consent
- Able to travel to the SFVA Medical Center or UCSF Medical Center for follow-up
examination
Exclusion Criteria:
- Age >90 or < 18 years
- Diagnosed hypercoaguble state
- Recent surgery or other major illness or infection within 6 weeks
- Use of immunosuppresive medication
- History or organ transplantation
- Pregnancy or plans to become pregnant
- Estimated life expectancy is less than 1 year
|
| NCT ID: |
|
NCT01604473 |
| Primary Contact: |
|
Principal Investigator
Christopher D Owens, M.D., M.Sc
University of California, San Francisco
Hugh F Alley
Phone: 415-221-4810 ext. 4708
Email: Hugh.Alley@ucsfmedctr.org
|
| Backup Contact: |
|
Email: Christine.Hall@ucsfmedctr.org
Christine Hall
Phone: 415-221-4810 ext. 2115
|
| Location Contact: |
|
San Francisco, California 94143
United States
Joy Walker, M.D.
Phone: 415-353-4366
Email: Joy.PeacockWalker@ucsfmedctr.org
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|